医用电气设备—第2-71部分：功能性近红外光谱仪的基本安全和基本性能的特殊要求

[中文适用范围]： IEC 80601-2-71:2025适用于定义在201.3.205节中功能性近红外光谱仪设备的基本安全性和基本性能，该设备旨在单独使用或作为ME系统的一部分，此处统称为ME设备。 本文件未涵盖在此文档范围内ME设备或ME系统的固有危害，除非在IEC 60601-1:2005、IEC 60601-1:2005/AMD1:2012和IEC 60601-1:2005/AMD2:2020的7.2.13和8.4.1节中有具体要求。 本文件不适用于以下设备： ——用于测量微血管（毛细血管、动脉和静脉）中的血红蛋白氧饱和度的设备，即组织oximeter； ——频域和时域功能性近红外光谱仪设备； ——用于测量除氧合和还原血红蛋白以外的其他色原浓度变化的设备； ——用于测量脑部以外组织中氧合和还原血红蛋白浓度变化的设备。 本文件未规定以下要求： ——脑组织oximeter设备，其要求见ISO 80601-2-85；以及 ——脉搏oximeter设备，其要求见ISO 80601-2-61。 IEC 80601-2-71:2025取消并替代了于2015年首次发布的第一版。本版构成技术修订。 与前一版本相比，本版包含以下重要技术变更： a) 与IEC 60601-1:2005、IEC 60601-1:2005/AMD1:2012、IEC 60601-1:2005/AMD2:2020、IEC 60601-1-8:2006、IEC 60601-1-8:2006/AMD1:2012、IEC 60601-1-8:2006/AMD2:2020、IEC 60601-1-2:2014、IEC 60601-1-2:2014/AMD1:2020、IEC 60601-1-6:2010、IEC 60601-1-6:2010/AMD1:2013和IEC 60601-1-6:2010/AMD2:2020进行对齐； b) 增加了基本性能的要求； c) 增加了主要操作功能的要求； d) 增加了防止过热保护的要求； e) 为穿戴个人防护装备的操作员增加了显示的可读性要求； f) 在适当的情况下与ISO 20417进行了协调。 [外文原描述]： IEC 80601-2-71:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of FUNCTIONAL NIRS EQUIPMENT, as defined in 201.3.205, intended to be used by itself, or as a part of an ME SYSTEM hereinafter referred to as ME EQUIPMENT. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, 7.2.13 and 8.4.1. This document is not applicable to – equipment for the measurement of oxygen saturation of the haemoglobin in the micro vessels (capillaries, arterioles and venules), i.e. tissue oximeters; – frequency-domain and time-domain equipment for functional near-infrared spectroscopy; – equipment for the measurement of changes in the concentration of chromophores other than oxy- and deoxy-haemoglobin; – equipment for the measurement of changes in the concentration of oxy- and deoxy-haemoglobin in tissues other than the brain. This document does not specify the requirements for: – cerebral tissue oximeter equipment, which are given in ISO 80601-2-85; and – pulse oximeter equipment, which are given in ISO 80601-2-61. IEC 80601-2-71:2025 cancels and replaces the first edition published in 2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) alignment with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020, IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012, IEC 60601-1-8:2006/AMD2:2020, IEC 60601-1-2:2014, IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020; b) added requirements for ESSENTIAL PERFORMANCE; c) added requirements for PRIMARY OPERATING FUNCTIONS; d) added requirements for protection against excessive temperatures; e) added requirements for the display legibility for OPERATORS wearing personal protective equipment; f) harmonization with ISO 20417, where appropriate.